Precision Treatment Study for Depression, Bipolar Disorder, and Schizophrenia Using Pharmacogenomic Guidance and Drug Monitoring in Chinese Han Adults

What this Trial Is About

Schizophrenia, major depressive disorder, and bipolar disorder are common and disabling mental health conditions that cause significant challenges for patients, families, and society. This research aims to develop a precision treatment model tailored to the Chinese Han population, combining pharmacogenomic testing, quantitative assessment-based treatment, and therapeutic drug monitoring. The goal is to improve treatment outcomes, safety, efficiency, and reduce costs for patients with these psychiatric disorders. Participants are randomly assigned to one of two groups. In the Guided group, treatment choices and dosages are adjusted based on pharmacogenomic test results received within 3 to 5 working days, with dose changes made within two weeks to reach stable dosing. Treatments include antipsychotic monotherapy for schizophrenia, antidepressants for major depressive disorder, and mood stabilizers such as lithium or valproic acid for bipolar disorder, with additional medications added if symptoms persist. The Unguided group receives standard symptom-based treatment without pharmacogenomic guidance during the 12-week observation, with test results shared only after the study ends. Participants undergo clinical assessments at 4, 8, and 12 weeks using scales like PANSS, HAMD, and YMRS to measure symptom changes. Additional evaluations include medication adherence, plasma drug levels, social performance, and safety monitoring at these timepoints and at 6 and 12 months. The study lasts 12 weeks with ongoing follow-up assessments to monitor treatment effects and safety, providing a comprehensive evaluation of this precision treatment approach.

Development and Application of Precision Treatment Strategies for Common Mental Disorders